The Effect of Pregnancy on the PK of Isentress®: A Longit... | NCT01251601

Studies
The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters

NCT01251601

Sponsor

University of North Carolina, Chapel Hill

Status

Withdrawn

Last Update Posted

Feb 28, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

HIV
Pregnancy

Interventions

Pharmacokinetics

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn due to inability to recruit eligible participants

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Dec 1, 2010

First Posted Date

Dec 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raltegravir in Pregnancy		HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy	Other: Pharmacokinetics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacokinetics	Other	Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum	Raltegravir in Pregnancy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV Infected
Pregnant
At least 18 years of age
Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum

Exclusion Criteria:

Less than 18 years of age
Hemoglobin <9 g/dL or Hematocrit <27.3 at screening

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients will be recruited by their HIV clinic providers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela DM Kashuba, PharmD	UNC Chapel Hill	Principal Investigator
Kristine B Patterson, MD	UNC Chapel Hill	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010599	Pharmacokinetics

Ancestor Terms

ID	Term
D008660	Metabolism
D002620	Pharmacological and Toxicological Phenomena
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided